Traditional Balloon kyphoplasty is a minimally invasive treatment that is used to relieve pain in patients that have vertebral body fractures or vertebral compression fractions caused by osteoporosis, cancer, or benign lesions. During traditional kyphoplasty, one or two independent balloons are used to create a cavity in the trabecular bone and restore vertebral body height, thereby allowing orthopedic cement to be injected to and stabilize the fracture.
The traditional kyphoplasty has been a successful tool for practitioners to help relieve pain for patients with kyphosis and vertebral body fractures. Several failures during traditional kyphoplasty have plagued practitioners, however. They include, for example, issues of iatrogenic cortical rim fracture created during inflation of balloon at the vertebral endplates. This complication is caused because standard kyphoplasty balloon is only controlled from the proximal end nearest the surgeon. The distal end of the standard kyphoplasty balloon is not controlled. During inflation, equal distribution of pressure of the balloon places the distal tip of standard kyphoplasty balloon in places unintended by the practitioner. Other predisposing factors for vertebral cortical fracture may be the presence of heterogeneous bone structures affecting balloon placement. This can lead to nonuniform balloon expansion during traditional unipedicle or bipedicle balloon kyphoplasty leading to subsequent cortical rim fracture. Thus, there exists a need to improve the kyphoplasty surgery that allows the practitioner to have full control and maneuverability of the kyphoplasty balloon from both a proximal and distal end, thereby allowing for the controlled expansion of the balloon as a precursor to cement placement.